[Apr 09, 2022] RAC-GS Exam Dumps, RAC-GS Practice Test Questions
Free RAC-GS Study Guides Exam Questions and Answer
NEW QUESTION 11
Which of the following is an example of an acceptable statement for an advertisement of an approved
arthritis medication?
- A. "Product X is effective in all patients with arthritis."
- B. "Product X is safe for arthritis and without side effects."
- C. "Product X is effective for the treatment of arthritis."
- D. "Product X is a guaranteed cure for arthritis."
Answer: C
NEW QUESTION 12
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
- A. Fault tree analysis
- B. Fishbone analysis
- C. Quality by design analysis
- D. Failure modes, effects, and criticality analysis
Answer: D
NEW QUESTION 13
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. ICH guidelines
- C. IEC 60601
- D. ISO 13485
Answer: D
NEW QUESTION 14
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Contact the marketing department to recall the product.
- B. Request that doctors stop using the product for the off-label indication.
- C. Communicate with the sales department to stop using the promotional materials.
- D. Allow doctors to use the product for the off-label indication.
Answer: C
NEW QUESTION 15
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical
device?
- A. Risk management
- B. Risk estimation
- C. Risk control
- D. Risk analysis
Answer: D
NEW QUESTION 16
A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?
- A. Justification
- B. Property
- C. Formulation
- D. Specification
Answer: A
NEW QUESTION 17
A process is ultimately validated to ensure which of the following?
- A. The process meets the regulatory requirements.
- B. The process consistently meets the desired Quantity standards
- C. The process meets the quality system requirements.
- D. The process consistently produces the desired results.
Answer: D
NEW QUESTION 18
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the
manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Quality improvement
- B. Clinical affairs
- C. Regulatory agency
- D. Quality assurance
Answer: D
NEW QUESTION 19
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a
holiday season when most of the staff Is not available. What is the MOST practical approach to this
dilemma?
- A. Insist that key personnel be available for the inspection.
- B. Inform the authority that the time is not suitable and request a new time
- C. Arrange for an inspection without all intended personnel.
- D. Negotiate with colleagues and the authority to find a better time.
Answer: D
NEW QUESTION 20
According to ICH, how many stability time points are normally required to establish a two-year shelf life for
a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: C
NEW QUESTION 21
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?
- A. Introduction of the API starting material
- B. Production of Intermediate(s)
- C. Isolation and purification
- D. Physical processing and packaging
Answer: D
NEW QUESTION 22
You discover that your company's top selling product in the last two years has been used off-label. The
off-label use is estimated to be about 70%, and it has been consistent since the product was first released
to the market. Which of the following is MOST appropriate?
- A. File a report to regulatory authorities and advise the marketing department to prevent future off-label
use. - B. No action is required since it is an off-label use.
- C. Advise the senior management to send a "Dear Dr." letter.
- D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
Answer: D
NEW QUESTION 23
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?
- A. The country's regulatory authority
- B. The ISO Secretariat
- C. The ISO national member body
- D. The ISO technical committee in charge of the area
Answer: C
NEW QUESTION 24
At a recent scientific meeting, Company Y had two booths:
. At one booth, Company Y provided brochures on a completed Phase II study.
. In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed
products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting
that Company Y stop this practice in the future and demanding a formal response to the letter. How
should the regulatory affairs professional at Company Y BEST respond?
- A. Acknowledge receipt of the letter in a written response but do nothing further.
- B. Inform the legal department of the letter and discuss how to respond.
- C. Inform Company X that it has no right to send such a letter and do nothing further.
- D. Inform the local regulatory authority of the letter and discuss how to respond.
Answer: B
NEW QUESTION 25
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage
should the manufacturer be able to trace back the product?
- A. Product distribution
- B. Plasma pooling
- C. Individual plasma donation
- D. Plasma fractionation
Answer: A
NEW QUESTION 26
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk reduction
- B. Risk evaluation
- C. Risk acceptance
- D. Risk analysis
Answer: C
NEW QUESTION 27
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?
- A. Class B
- B. Class A
- C. Class D
- D. Class C
Answer: D
NEW QUESTION 28
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase I clinical trials
- B. Pre-clinical studies
- C. Phase III clinical trials
- D. Phase I and II clinical trials
Answer: C
NEW QUESTION 29
One month prior to the anticipated approval date for your product, the marketing application that you
submitted to a major regulatory authority has become the subject of an advisory committee meeting of
experts convened by the regulatory authority. The advisory committee members unanimously vote not to
approve your product because of a safety concern. Two days after the advisory committee meeting, the
regulatory authority requests additional information to support the safety of your product. Assuming you
have no additional data to provide, which of the following would be your MOST appropriate response to
the regulatory authority's request?
- A. "We disagree with the advisory committee's decision because the committee neglected the thorough
safety analysis that we provided." - B. "We have no additional information to provide at this time because we have already provided
everything needed to support our product's approval." - C. "We have no additional information to provide at this time, but we can perform an additional analysis for
a specific safety concern, if necessary." - D. "Given the advisory committee's unanimous decision, we know that the product will not be approved,
and additional data will not make any difference."
Answer: C
NEW QUESTION 30
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level,
the medical device continues to have unacceptable risks. However, the development team wants to
continue development. Which is the BEST recommendation to make in this situation?
- A. Perform another risk-benefit analysis.
- B. Redesign the device.
- C. Add a warning in the IFU.
- D. Discontinue the project.
Answer: B
NEW QUESTION 31
Which of the following criteria is MOST appropriate to define the animal species needed for the
pre-clinical toxicity testing of a biotechnology product?
- A. Immunochemical and functional tests
- B. Biological activity with species and/or tissue specificity
- C. Proposed product route and frequency of administration
- D. Proposed dose and volume of administration
Answer: B
NEW QUESTION 32
A materials supplier informs a company that it intends to stop supplying a material critical to the
manufacture of the company's products. What action should the company take FIRST?
- A. Reformulate the products with a replacement material.
- B. Qualify another supplier and execute a supplier agreement.
- C. Complete a gap analysis to identify options.
- D. Review the company's existing Quality Management System
Answer: B
NEW QUESTION 33
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. As many as required by international standards
- B. As many as government attendees
- C. All senior management from the main office
- D. The minimum number of attendees necessary to address the issues
Answer: D
NEW QUESTION 34
Which of the following claims would classify an apple as a drug?
- A. "It will satisfy hunger."
- B. "It will whiten teeth."
- C. "It will prevent colds."
- D. "It will make you look younger."
Answer: C
NEW QUESTION 35
The intermediate manufacturing process was changed during development of a pharmaceutical. The
change may impact the API specification. Which functional area is responsible for the final approval of the
change?
- A. Production
- B. Analytical
- C. Regulatory
- D. Quality
Answer: D
NEW QUESTION 36
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